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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032845
Receipt No. R000037445
Scientific Title A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Date of disclosure of the study information 2018/09/01
Last modified on 2019/06/03

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Basic information
Public title A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Acronym A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title:Acronym A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 preventional efficacy of body composition decline (body weight, muscle mass, fat mass)

nutrition index (Alb, TP, T-Chol, prealubmin, NLR)

compliance of adjuvant chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes change rate of mascle mass 6 months after intervention
Key secondary outcomes change rate of body weight and fat mass 6 months after intervention
nutrition index
compliance of adjuvant chemotherapy
drug safty

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dayly administration of ELENTAL (300kcal) for 6 months from the start of adjuvant chemotherapy
Interventions/Control_2 Dayly administration of ELENTAL (300kcal) and Rikkunshito 7.5g for 6 months from the start of adjuvant chemotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who received R0 resection by distal or proximal gastrectomy
2) Patients who will receive adjuvant chemotherapy
3) Patients with apptite loss or malnutrition on POD 7
4) Patients without severe complications (heart disease, pulmonary fibrosis, intestinal pneumonia, bleeding tendency)
5) Patients who will be alive for more than 6 months
6) Patients who can take oral nutrition
7) Patients whose age is more than 20
8) Patients who approved written informed consent
Key exclusion criteria 1) Patients with another malignant neoplasm
2) Patients who received preoperative chemo- or radiotherapy
3) Patients with preoperative malnutrition (alb less than 3.0g per dl)
4) Patients who were administrated Kanpo
5) Patients with allergy of ELENTAL
6) Patients with history of Kanpo allergy
7) Patients with severe psychiatric disorder
8) Patients who was considered ineligible by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Sachio
Middle name
Last name Fushida
Organization Kanazawa University Hospital
Division name Gastroenterological Surgery
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Email fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Sachio
Middle name
Last name Fushida
Organization Kanazawa University Hospital
Division name Gastroenterological Surgery
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Homepage URL
Email fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute NPO corporation Digestive Disorder Support Organization (DDSO)
Institute
Department

Funding Source
Organization NPO corporation Digestive Disorder Support Organization (DDSO)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takara-machi, Kanazawa
Tel 076-265-2000
Email hpsangak@adm.kanazawa-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
2018 Year 10 Month 03 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 02 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037445

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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